Director of Regulatory Affairs (Generic)
Large international Generic company with over 100 products in its pipeline is expanding operations in the United States. With an aggressive submissions schedule of over 15 ANDA's and over 12 DMF's, the company is looking for someone with strong generic experience to establish and grow their Regulatory Department. This role reports directly to the President of the US operation.

Responsibilities:
Planning and execution of drug submissions to the FDA and other Federal and State agencies.
Coordinating responses to inquiries from such agencies, and for maintaining the company’s growth portfolio of approved drug applications.

REQUIREMENTS:
A Bachelor/Masters in a scientific field, with ten plus years of increasing responsibility in regulatory affairs. Thorough knowledge of all FDA requirements for preparation and maintenance of NDA's, ANDA's as well as DMF's. Prior experience interacting directly with FDA representatives is essential, prior experience working with the Division of Neuropharmacological Drug Products is highly desirable, and prior experience working with the Drug Enforcement Administration is a plus. Excellent interpersonal skills, excellent communication skills, including the ability to conceptualize, plan, and execute all types of submissions to the FDA are required. Time management and planning skills are essential in order that the incumbent may simultaneously plan and execute a variety of tasks needed to meet submission goals and other company priorities.